UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The short-term efficacy of very low-frequency repetitive transcranial magnetic stimulation (rTMS) over the unaffected motor cortex on post-stroke patients with spasticity recieving botulinum toxin injection and rehabilitation
Title of the study (Brief title)	The short-term efficacy of very low-frequency repetitive transcranial magnetic stimulation (rTMS) over the unaffected motor cortex on post-stroke patients with spasticity recieving botulinum toxin injection and rehabilitation
Region	Japan

Condition
Condition	stroke
Classification by specialty	Medicine in general Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety of very low-frequency repetitive transcranial magnetic stimulation over the unaffected motor cortex in post-stroke patients with spasticity recieving botulinum toxin injection and rehablititaion
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	manual muscle test, handgrip, Brunnstrom stage, modified Ashworth scale,10m gait speed,Timed up and go test, Fugel-Myer Assessment(FMA), Wolf Motor Function Test(WMFT), SF36
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	repetitive transcranial magnetic stimulation
Interventions/Control_2	sham stimulation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Patients are in the post -stroke period over one year following onset. (2)History of a single stroke only (3)No cognitive disorders (4)No depression (5)No active physical and psychological disorders
Key exclusion criteria	(1)Seizures for the past year (2)Current use of antiepileptic medications for the prevention of seizure (3)Implanted medical device (4)Intracranial magnetic material (5)Pregnant or intented to be pregnant
Target sample size	100

Research contact person
Name of lead principal investigator	Ryuji Kaji
Organization	Tokushima university hospital
Division name	Department of Neurology
Address	2-50-1 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL	088-633-7207
Email	kajkyoto@mbox.kyoto-inet.or.jp

Public contact
Name of contact person	Takeuchi Toshiaki
Organization	Tokushima university hospital
Division name	Department of Neurology
Address	2-50-1 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL	088-633-7207
Homepage URL
Email	takeuchi.toshiaki@tokushima-u.ac.jp

Sponsor
Institute	Department of neurology, Tokushima university hospital
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 08 Month 10 Day
Anticipated trial start date	2012 Year 08 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 10 Day
Last modified on	2016 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010181